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Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study
BACKGROUND: There is a permanent need to evaluate and develop the ethical quality of scientific research and to widen knowledge about the effects of ethical issues. Therefore we evaluated whether informed consent is related to implementation and success in a lifestyle intervention study with older r...
Autores principales: | , , , , |
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Formato: | Texto |
Lenguaje: | English |
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BioMed Central
2010
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2891796/ https://www.ncbi.nlm.nih.gov/pubmed/20529340 http://dx.doi.org/10.1186/1472-6939-11-9 |
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author | Länsimies-Antikainen, Helena Pietilä, Anna-Maija Laitinen, Tomi Kiviniemi, Vesa Rauramaa, Rainer |
author_facet | Länsimies-Antikainen, Helena Pietilä, Anna-Maija Laitinen, Tomi Kiviniemi, Vesa Rauramaa, Rainer |
author_sort | Länsimies-Antikainen, Helena |
collection | PubMed |
description | BACKGROUND: There is a permanent need to evaluate and develop the ethical quality of scientific research and to widen knowledge about the effects of ethical issues. Therefore we evaluated whether informed consent is related to implementation and success in a lifestyle intervention study with older research participants. There is little empirical research into this topic. METHODS: The subjects (n = 597) are a subgroup of a random population sample of 1410 men and women aged 57-78 years who are participating in a 4-year randomized controlled intervention trial on the effects of physical exercise and diet on atherosclerosis, endothelial function and cognition. Data were collected in two steps: A questionnaire about informed consent was given to all willing participants (n = 1324) three months after the randomization. Data on implementation and success in the exercise and diet interventions were evaluated at 12 months by intervention-group personnel. The main purpose of the analysis procedure performed in this study was to identify and examine potential correlates for the chosen dependent variables and to generate future hypotheses for testing and confirming the independent determinants for implementation and success. The nature of the analysis protocol is exploratory at this stage. RESULTS: About half of the participants (54%) had achieved good results in the intervention. Nearly half of the participants (47%) had added to or improved their own activity in some sector of exercise or diet. Significant associations were found between performance in the interventions and participants' knowledge of the purpose of the study (p < 0.001), and between success in interventions and working status (p = 0.02), and the participants' knowledge of the purpose of the study (p = 0.04). CONCLUSION: The main finding of this study was that those participants who were most aware or had understood the purpose of the study at an early stage had also attained better results at their 12-month intervention evaluation. Therefore, implementation and success in intervention is related to whether subjects receive a sufficient amount and are able to comprehend the information provided i.e. the core principles of informed consent. TRIAL REGISTRATION: (ISRCTN 45977199) |
format | Text |
id | pubmed-2891796 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-28917962010-06-25 Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study Länsimies-Antikainen, Helena Pietilä, Anna-Maija Laitinen, Tomi Kiviniemi, Vesa Rauramaa, Rainer BMC Med Ethics Research article BACKGROUND: There is a permanent need to evaluate and develop the ethical quality of scientific research and to widen knowledge about the effects of ethical issues. Therefore we evaluated whether informed consent is related to implementation and success in a lifestyle intervention study with older research participants. There is little empirical research into this topic. METHODS: The subjects (n = 597) are a subgroup of a random population sample of 1410 men and women aged 57-78 years who are participating in a 4-year randomized controlled intervention trial on the effects of physical exercise and diet on atherosclerosis, endothelial function and cognition. Data were collected in two steps: A questionnaire about informed consent was given to all willing participants (n = 1324) three months after the randomization. Data on implementation and success in the exercise and diet interventions were evaluated at 12 months by intervention-group personnel. The main purpose of the analysis procedure performed in this study was to identify and examine potential correlates for the chosen dependent variables and to generate future hypotheses for testing and confirming the independent determinants for implementation and success. The nature of the analysis protocol is exploratory at this stage. RESULTS: About half of the participants (54%) had achieved good results in the intervention. Nearly half of the participants (47%) had added to or improved their own activity in some sector of exercise or diet. Significant associations were found between performance in the interventions and participants' knowledge of the purpose of the study (p < 0.001), and between success in interventions and working status (p = 0.02), and the participants' knowledge of the purpose of the study (p = 0.04). CONCLUSION: The main finding of this study was that those participants who were most aware or had understood the purpose of the study at an early stage had also attained better results at their 12-month intervention evaluation. Therefore, implementation and success in intervention is related to whether subjects receive a sufficient amount and are able to comprehend the information provided i.e. the core principles of informed consent. TRIAL REGISTRATION: (ISRCTN 45977199) BioMed Central 2010-06-08 /pmc/articles/PMC2891796/ /pubmed/20529340 http://dx.doi.org/10.1186/1472-6939-11-9 Text en Copyright ©2010 Länsimies-Antikainen et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research article Länsimies-Antikainen, Helena Pietilä, Anna-Maija Laitinen, Tomi Kiviniemi, Vesa Rauramaa, Rainer Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study |
title | Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study |
title_full | Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study |
title_fullStr | Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study |
title_full_unstemmed | Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study |
title_short | Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study |
title_sort | is informed consent related to success in exercise and diet intervention as evaluated at 12 months? dr's extra study |
topic | Research article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2891796/ https://www.ncbi.nlm.nih.gov/pubmed/20529340 http://dx.doi.org/10.1186/1472-6939-11-9 |
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